BioControl Medical Gets Nod to Begin Second Phase of the INOVATE-HF Study of Its CardioFit System

July 12, 2012 — BioControl Medical has announced U.S. Food and Drug Administration (FDA) approval to begin the second phase of INOVATE-HF (Increase Of Vagal Tone in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical study of the company’s CardioFit system for heart failure. The approval, which is based on the successful completion of an initial phase involving 50 patients at 21 centers worldwide, allows unconditional study expansion of up to 200 patients at 50 U.S. centers.

Initiated in April 2011, INOVATE-HF is a prospective, randomized, controlled clinical study to determine the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure (HF). The study will evaluate the system’s potential to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.

INOVATE-HF is designed to explore the CardioFit’s potential to help treat one of the hallmarks of HF: an imbalance in the autonomic nervous system, which regulates involuntary bodily functions including heart muscle activity. In healthy individuals, the two branches of the autonomic nervous system, called the sympathetic and the parasympathetic, work in concert to regulate the heart. At the most basic level, the sympathetic increases cardiovascular activity, while the parasympathetic decreases it. In people with HF, the balance between these two branches is disrupted, leading to added stress on the heart and progressive deterioration of cardiovascular function.

While prescription medications have been successful at treating the sympathetic branch to reduce select symptoms, there have been no treatments designed to specifically and safely target the parasympathetic branch. CardioFit was developed to activate the parasympathetic nervous system directly to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.

INOVATE-HF will ultimately enroll up to 650 patients at up to 80 centers in the United States and Europe. Results of the INOVATE-HF study will be used to support a premarket approval (PMA)application to the FDA for market clearance of CardioFit.